NCT06893341

Monitoring Exhaled Breath to Noninvasively Detect Glycemic Events

Monitoring Volatile Organic Compound Profiles in Exhaled Breath to Noninvasively Detect Glycemic Events in Patients With Diabetes

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 12 Years – 19 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether an array of biosensors can noninvasively identify hyperglycemic or hypoglycemic events in persons diagnosed with diabetes through noninvasive detection of volatile organic compounds in exhaled breath.

Detailed description

A device has been developed for sensing volatile organic compounds (VOCs) from human breath. VOCs are chemicals in the air that make up scents and smells, and many VOCs are endogenously produced inside the human body. Trained dogs can smell exhaled breath to determine if someone has diabetes and can even distinguish hypo- or hyperglycemic events (low or high blood sugar). The purpose of this study is to determine if the sensor device can identify hypo- or hyperglycemic events in persons with diabetes through detecting VOCs in breath noninvasively. The data obtained from the VOC sensor will be compared to the information that is also gathered from a continuous glucose monitor (CGM) to establish correlations between blood glucose and exhaled VOC measurements.

Conditions

• Diabetes
• Hyperglycemia
• Hypoglycemia

Interventions

Type	Name	Description
DEVICE	The Sensing Device	Children diagnosed with diabetes that wear a continuous glucose monitor will be given the Sensing Device. The subjects will provide breath samples into the device during euglycemia, hypoglycemia, and hyperglycemia, and the breath data will be analyzed to draw correlations with blood glucose levels.

Timeline

• Start date: 2025-10-23
• Primary completion: 2026-04-01
• Completion: 2026-04-01
• First posted: 2025-03-25
• Last updated: 2026-02-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study